FDA finally issues ruling on e-cigarettes

At long last, after TWO years of deliberations, the Food and Drug Administration earlier this week FINALLY issued a ruling on e-cigarette (and tobacco) regulation.

Unfortunately, this came at a time when I was really busy, plus I wanted to take a few days to digest the news.

My initial reaction to the news was disappointment that the FDA will do nothing to control e-cigarette marketing, online sales or candy flavourings. The biggest obvious change is the sale of e-cig products to minors will be banned. However, over 40 states already ban e-cig sales to minors, so this ruling is a bit cosmetic.

However, then I started reading comments from the e-cigarette industry absolutely FREAKING OUT over these regs, and I started thinking, “wow, if the e-cigarette industry is so pissed off, the regs can’t be that bad.”

It turns out the FDA ruling is pretty complex, and I’m personally still sifting through it to see what it means, and I fully expect to be writing more posts about this over the next several weeks and months. I saw several headlines that screamed, “E-cigarettes virtually banned.” Here’s what they’re talking about and what turns out might be the biggest effect of this ruling: The FDA will require that all tobacco products (which under the FDA definition includes e-cigs even though they don’t actually contain tobacco — they do contain nicotine) that hit the market since 2007 must be individually approved by the FDA. E-cigs were basically non-existent before 2007, so this affects nearly all e-cig products.

That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.

One million dolalrs each for every flavour? Holy cow, on the face of it, that would cripple the industry. Sure enough, industry leaders are incensed.

Ray Story, the founder and CEO of the Tobacco Vapor Electronic Cigarette Association, called the ruling “a complete disaster.” Since 2009, his association has advocated for a change in the law that would require age verification and restrict sales to minors.

“No children should have access to these products. Just like with alcohol, these are adult products,” he said.

What he takes issue with is the FDA requirement for approval on the products, down to the batteries. He said the rule “essentially bans the product across the land.”

E-cigarette shouldn’t be sold to minors, and government should restrict advertising so they aren’t marketed to kids. But the FDA’s drastic overstep today will require e-cigarettes not already on the market by February 2007 to undergo a costly and onerous Premarket Tobacco Application process that holds e-cigarettes to a standard nearly impossible to prove, and one that well-established actual cigarettes don’t have to face.

By the way, this commentary was actually written by Jeff Stier, who is from an organization called the National Center for Public Policy Research, which is described by Wikipedia as a “conservative think tank.” These are the same kind of “think tanks” that claimed for decades that there was no proof that smoking caused lung cancer or that secondhand smoke was completely harmless. If that wasn’t convincing enough … the National Center for Public Policy Research actually receives some of its funding from Big Tobacco and Big E-Cig (Which is rapidly becoming a wholly owned subsidiary of Big Tobacco). So take this hyperbole with as many grains of salt as you please. I take it was LOT of grains of salt.

Now, it could be these industry folks are being hyperbolic as hell. I remember back in the day everyone thought the 1998 Master Settlement Agreement was going to be the death of Big Tobacco. But, I love that the e-cig industry is freaking out. GOOD. They deserve to freak out.

Here’s why. I walk a fine line with e-cigs. I get it that e-cigs genuinely help some people get off cigarettes. There’s mixed data about the effectiveness of e-cigs as a tool for smoking cessation. But, I’ve seen enough anecdotal information online about people praising them for helping to get them off cigarettes to believe that they have a genuine value.

However, here is the problem with e-cigs. It has been painfully clear to people actually paying attention that e-cigs are blatantly marketing their products to kids … using actors dressed up as race car drivers, using women’s panties, even using Santa Clause … to sell e-cigs. Jesus …even Santa Clause? Big Tobacco did this kind of stuff 60 years ago, heck they were still using race car imagery with Joe Camel as recently as 20 years ago.

They’re using this hip, young, active, savvy, sexy imagery to addict teenagers to nicotine. For all of the benefits of e-cigs, and it appears there are some real benefits, it’s still a delivery system for nicotine. And nicotine is one of the most addictive substances on the planet. And people still don’t know what all is in e-cigarette steam. We know it contains formaldehyde and another chemical called diacetyl, which causes a disease known as “popcorn lung.”

From another very well-written USA Today editorial, this written by the USA Today editorial board of directors, appropriate titled “FDA takes e-cigs out of ‘wild West'”:

Once before, the nation let an addictive product get by with little regulation. By the time the surgeon general first warned of cigarettes’ deadly dangers in 1964, about four in 10 Americans were already hooked. It has taken more than 50 years and a costly war on smoking to cut that adult rate in half and to bring teen smoking down to about 9%.

No wonder the government and public health advocates are wary of these new “vaping” products, which also contain nicotine, and some of which are made by the same companies that brought the nation Joe Camel and the Marlboro Man.

While advocates for e-cigarettes talk about their potential upside in the future — getting smokers to quit — they seldom acknowledge the facts on the ground right now: E-cig use among teenagers is exploding. Last year, 16% of high school students used e-cigarettes at least once in the past month, making the devices more popular than traditional cigarettes among teens, according to a national survey by the federal government. That’s up from 1.5% in 2011 — an astounding rise.

Promoters argue that teens are switching to a safer product. Great if true. But some earlier data show that many teens who use e-cigarettes have not smoked traditional cigarettes before. Exactly how many fit that description now is a key question that researchers need to sort out.

Industry players also underscore that their products are only for adults. Their advertising says otherwise: The women who vape are sexy and glamorous, the men rugged and rebellious, the very themes that attracted generations of teens to traditional cigarettes. In stores, e-cigarettes are sold above ice cream freezers, next to candy and in flavors that include Cherry Crush and Gummy Bear. About 85% of youths who had used e-cigs in the past 30 days used ones that were flavored.

Game. Set. Match. Thank you, USA Today.

These rules will not go into effect immediately. I was initially deeply disappointed in the lack of regs over e-cig marketing (I believe the FDA was wary of going here because of fears over First Amendment lawsuits, and guess what, if the FDA loses a First Amendment lawsuit over e-cigs, that might affect the federal government’s ability to regulate marketing of cigarettes.). I don’t get as worked up about the candy flavouring because so many adult users have told me they like the sweet flavours, too, but I know a lot of anti-tobacco advocates hate that e-cigs are allowed to have sugary flavours.

But, this subtle little language about requiring all e-cig products to be approved by the FDA might reel in this out-of-control industry, which is selling a drug and is selling an addictive drug … to kids … with a wink and a nod … “Moi? Not us!”

Now, there is apparently legislation in Congress to push up this 2007 date and grandfather current e-cig products so they wouldn’t require individual review by the FDA. Golly wonder whose lobbyists might be behind that? I hope Obama and any other future Democratic president vetoes any such legislation that reaches his or her desk. The e-cig industry is a multi-billion dollar industry, about 40 percent of which is actually owned by Big Tobacco. It can damn well pony up to have its products approved fair and square.